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Total knee arthroplasty assisted by intelligent extramedullary positioning system

Total knee arthroplasty assisted by intelligent extramedullary positioning system

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100053059
Enrollment
Unknown
Registered
2021-11-10
Start date
2021-11-30
Completion date
Unknown
Last updated
2022-09-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Total knee arthroplasty

Interventions

Experimental group:Intraoperative femoral localization was assisted by IKPAS intelligent extramedullary localization system
Control group:Traditional intramedullary localization was used for femoral localization during TKA

Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Aged 18 to 80 years, regardless of gender; 2.The patient was diagnosed as a patient with knee osteoarthritis who failed to respond to conservative treatment; 3.Patients assessed by the investigator as requiring the first unilateral total knee arthroplasty; 4.The subjects fully understand the benefits and risks of this trial and are willing to participate and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Body mass index (BMI) >35kg/m^2; 2.Patients with heart failure, lung and other important organ failure; 3.Abnormal liver and kidney function (ALT, AST> normal value 1.5 times, blood BUN>-8.3 mmoll, blood Scr>115 umol/L); 4.Diabetic patients with poor control of blood sugar level; researchers judged risk of infection; 5.Combined with consciousness disorder or mental illness; 6.Having a history of open operation of knee joint; 7.Neuromuscular dysfunction affects the function of lower limbs; 8.Patients with severe coagulation dysfunction; 9.Complicated with serious internal and surgical diseases or weak physique, unable to tolerate the operation; 10.Severe instability and incurable TKA with ligament preservation; 11.Active infection foci in the body (systemic or local infectious lesions); 12.There are serious osteoporosis, metabolic bone disease, radiation bone disease and tumor around the knee; 13.Family planning, lactation and pregnant women during the whole clinical study; 14.Patients who have participated in other clinical trials within 3 months; 15.Patients who the researchers think are not suitable to participate in this clinical trial for other reasons.

Design outcomes

Primary

MeasureTime frame
hip-knee-ankle (HKA);coronal plane tibial component angle;

Secondary

MeasureTime frame
sagittal tibial component angle;American knee society knee score;Western Ontario and McMaster University Osteoarthritis Index;vision algetic score;range of motion;operation time;total blood loss;

Countries

China

Contacts

Public ContactKang Pengde

West China Hospital of Sichuan University

kangpd@163.com+86 18980601953

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026